Sex-Specific Outcomes of Transcatheter Edge-to-Edge Repair for Degenerative Mitral Regurgitation: Results From the CLASP IID Trial

Abstract

Background

Female patients with degenerative mitral regurgitation (DMR) can have worse mitral valve repair outcomes. We aim to study sex-specific differences in contemporary mitral transcatheter edge-to-edge repair (M-TEER).

Methods

One-year outcomes in prohibitive surgical risk patients with 3+/4+ DMR from the randomized CLASP IID trial were analyzed by sex.

Results

The analysis population comprised 34.7% female patients (n = 102) and 65.3% male patients (n = 192). Female patients had significantly lower body mass index, fewer comorbidities, and smaller left ventricular indexed volumes and mitral valve area at baseline. At 1 year, there were no significant differences between female and male patients in survival (92.1% vs 90.9%, P = .754), freedom from heart failure hospitalization (91.7% vs 94.4%, P = .366), and freedom from major adverse events (86.0% vs 85.9%, P = .985), respectively. Both sexes achieved a significant reduction in mitral regurgitation from baseline at 1 year (P < .001), with comparable mitral regurgitation ≤1+ (75.6% vs 75.0%, P = 1.000). Baseline-adjusted changes in indexed left ventricular volumes (diastolic: –18.8 vs –15.7 mL, P = .087; systolic: –5.6 vs –5.0 mL, P = .645) and mitral gradients (+1.4 vs +1.1 mm Hg, P = .116) were similar, with no indication of stenosis. New York Heart Association class I/II was achieved in 86.4% of female patients vs 88.7% of male patients (P = .674), and the Kansas City Cardiomyopathy Questionnaire overall score increased by 14.1 vs 15.8 points (P = .502), respectively.

Conclusions

In the CLASP IID randomized trial, both sexes experienced high survival and freedom from major adverse events and heart failure hospitalization at 1 year post–M-TEER, with comparable improvements in echocardiographic, functional, and quality-of-life measures, despite differences in clinical presentation and the procedure. Results demonstrate that female patients achieve favorable safety and effectiveness outcomes, comparable to male patients, with contemporary M-TEER in DMR.